Debridement device and method

ABSTRACT

Devices, systems and methods for cutting and sealing of tissue such as bone and soft tissue. Devices, systems and methods include delivery of energy including bipolar radiofrequency energy for sealing tissue which may be concurrent with delivery of fluid to a targeted tissue site. Devices include debridement devices which may include a fluid source. Devices include inner and outer shafts coaxially maintained and having cutters for debridement of tissue. An inner shaft may include electrodes apart from the cutter to minimize trauma to tissue during sealing or hemostasis. Devices may include a single, thin liner or sheath for electrically isolating the inner and outer shafts.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/916,127, filed on Jun. 12, 2013, which claims the benefit of U.S.provisional application 61/658,724, filed Jun. 12, 2012 and of U.S.Provisional Application 61/704,904, filed Sep. 24, 2012, the entiredisclosures of which are hereby incorporated by reference in theirrespective entireties.

BACKGROUND

The present invention is generally directed to devices, systems andmethods for cutting and sealing tissue such as bone and soft tissue. Thepresent invention may be particularly suitable for sinus applicationsand nasopharyngeal/laryngeal procedures and may combine or provideTranscollation® technology with a microdebrider device.

Devices, systems and methods according to the present disclosure may besuitable for a variety of procedures including ear, nose and throat(ENT) procedures, head and neck procedures, otology procedures,including otoneurologic procedures. The present disclosure may besuitable for a varient of other surgical procedures includingmastoidectomies and mastoidotomies; nasopharyngeal and laryngealprocedures such as tonsillectomies, trachael procedures,adenoidectomies, laryngeal lesion removal, and polypectomies; for sinusprocedures such as polypectomies, septoplasties, removals of septalspurs, anstrostomies, frontal sinus trephination and irrigation, frontalsinus opening, endoscopic DCR, correction of deviated septums andtrans-sphenoidal procedures; rhinoplasty and removal of fatty tissue inthe maxillary and mandibular regions of the face.

Sinus surgery is challenging due to its location to sensitive organssuch as the eyes and brain, the relatively small size of the anatomy ofinterest to the surgeon, and the complexity of the typical procedures.Examples of debriders with mechanical cutting components are describedin U.S. Pat. Nos. 5,685,838; 5,957,881 and 6,293,957. These devices areparticularly successful for powered tissue cutting and removal duringsinus surgery, but do not include any mechanism for sealing tissue toreduce the amount of bleeding from the procedure. Sealing tissue isespecially desirable during sinus surgery which tends to be a complexand precision oriented practice.

Electrosurgical technology was introduced in the 1920's. In the late1960's, isolated generator technology was introduced. In the late1980's, the effect of RF lesion generation was well known. See e.g.,Cosman et al., Radiofrequency lesion generation and its effect on tissueimpedance, Applied Neurophysiology (1988) 51: 230-242. Radiofrequencyablation is successfully used in the treatment of unresectable solidtumors in the liver, lung, breast, kidney, adrenal glands, bone, andbrain tissue. See e.g., Thanos et al., Image-Guided RadiofrequencyAblation of a Pancreatic Tumor with a New Triple Spiral-ShapedElectrode, Cardiovasc. Intervent. Radiol. (2010) 33:215-218.

The use of RF energy to ablate tumors or other tissue is known. Seee.g., McGahan J P, Brock J M, Tesluk H et al., Hepatic ablation with useof radio-frequency electrocautery in the animal model. J Vasc IntervRadiol 1992; 3:291-297. Products capable of aggressive ablation cansometimes leave undesirable charring on tissue or stick to the tissueduring a surgical procedure. Medical devices that combine mechanicalcutting and an electrical component for cutting, ablating or coagulatingtissue are described, for example, in U.S. Pat. Nos. 4,651,734 and5,364,395.

Commercial medical devices that include monopolar ablation systemsinclude the Invatec MIRAS RC, MIRAS TX and MIRAS LC systems previouslyavailable from Invatec of Italy. These systems included a probe, agrounding pad on the patient and a generator that provides energy in therange of 450 to 500 kHz. Other examples of RF bipolar ablationcomponents for medical devices are disclosed in U.S. Pat. Nos. 5,366,446and 5,697,536.

Medical devices are also used to ablate heart tissue with RF energy.See, e.g., Siefert et al. Radiofrequency Maze Ablation for AtrialFibrillation, Circulation 90(4): I-594. Some patents describing RFablation of heart tissue include U.S. Pat. Nos. 5,897,553, 6,063,081 and6,165,174. Devices for RF ablation of cardiac tissue are typically muchless aggressive than RF used to cut tissue as in many procedures oncardiac tissue, a surgeon only seeks to kill tissue instead of cuttingor removing the tissue. Cardiac ablation of this type seeks to preservethe structural integrity of the cardiac tissue, but destroy the tissue'sability to transfer aberrant electrical signals that can disrupt thenormal function of the heart.

Transcollation® technology, for example, the sealing energy supplied bythe Aquamantys® System (available from Medtronic Advanced Energy ofPortsmouth, N.H.) is a patented technology which stops bleeding andreduces blood loss during and after surgery and is a combination ofradiofrequency (RF) energy and saline that provides hemostatic sealingof soft tissue and bone and may lower transfusion rates and reduce theneed for other blood management products during or after surgery.Transcollation® technology integrates RF energy and saline to delivercontrolled thermal energy to tissue. Coupling of saline and RF energyallows a device temperature to stay in a range which produces a tissueeffect without the associated charring found in other ablation methods.

Other ablation devices include both mechanical cutting as well asablation energy. For example, the PK Diego® powered dissector iscommercially available from Gyms ENT of Bartlett, Tenn. This deviceutilizes two mechanical cutting blade components that are moveablerelative to each other, one of which acts as an electrode in a bipolarablation system. The distal end portion of the device includes sixlayers to accomplish mechanical cutting and electrical coagulation. Thedual use of one of the components as both a mechanical, oscillatingcutting element and a portion of the bipolar system of the device isproblematic for several reasons. First, the arrangement exposes thesharp mechanical cutting component to tissue just when hemostasis issought. In addition, the electrode arrangement does not provide foroptimal application of energy for hemostasis since the energy is appliedessentially at a perimeter or outer edge of a cut tissue area ratherthan being applied to a central location of the cut tissue. Thearrangement of the device also requires more layers than necessary inthe construction of a device with both sharp cutters and RF ablationfeatures. The overabundance of layers can make it difficult to design asmall or optimally-sized distal end. Generally speaking, the larger thedistal end, the more difficult it is for the surgeon to visualize theworking surfaces of the device. The use of six layers at the distal endof the system also interferes with close intimate contact between thetissue and the electrodes. Some examples of cutting devices aredescribed in U.S. Pat. Nos. 7,854,736 and 7,674,263.

The Medtronic Straightshot® M4 Microdebrider uses sharp cutters to cuttissue, and suction to withdraw tissue. While tissue debridement withthe Medtronic microdebrider system is a simple and safe technique, somebleeding may occur. The Medtronic microdebrider does not include afeature dedicated to promoting hemostasis or bleeding management. Thus,nasal packing is often used.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, where like numerals refer to like components throughoutseveral views:

FIG. 1 is a perspective view of a system according to one aspect of thepresent invention;

FIG. 2 is a perspective view of a distal end region of a device with aninner shaft in a position according to one aspect of the presentinvention;

FIG. 3 is a perspective view of the distal end region of a device withan inner shaft in an alternative position according to one aspect of thepresent invention;

FIG. 4 is a perspective view the distal end region of FIG. 2 with anouter shaft removed to show portions of an inner shaft and insulationliner;

FIG. 5 is a perspective view of the distal end region of FIG. 4 with theinsulation liner removed to show additional portions of the inner shaftand electrode traces;

FIG. 6 is a perspective view of the distal end region of FIG. 5 with theelectrode traces removed;

FIG. 7 is a perspective view of the distal end region of FIG. 6 withcomponents removed;

FIG. 8 is a perspective view of another embodiment of a distal endportion of an outer shaft of a device according the present invention;

FIG. 9 is a perspective view the outer shaft of FIG. 8 showing a partialelectrode configuration according to an aspect of the present invention;

FIG. 10 is a perspective view of a proximal end of an inner shaftaccording to an aspect of the present invention;

FIG. 11 is a perspective view of a proximal end of a device showing abutton activation cell according to an aspect of the present invention;

FIG. 12 is a an exploded view of the button activation cell of FIG. 11according to an embodiment of the present invention;

FIG. 13 is a perspective view of portions of the button activation cellof FIG. 11 according to an aspect of the present invention;

FIG. 14 is a perspective view of the assembly of FIG. 13 with portionsremoved according to an aspect of the present invention;

FIG. 15 is a top view of the button activation cell of FIG. 10 accordingto an aspect of the present invention.

DETAILED DESCRIPTION

FIG. 1 illustrates a system 10 according to an aspect of the presentinvention. The system 10 includes a device 100 having a distal endregion indicated generally at 120 and a proximal end region indicatedgenerally at 110. The device includes an outer shaft 130 and an innershaft 140 coaxially maintained within the outer shaft 130. A portion ofthe inner shaft 140 is shown in FIG. 1 at distal end region 120.Proximal end region 110 includes a button activation cell 200 comprisinga housing 204 and a button 202, the proximal end region furthercomprising a hub 175 coupled to inner shaft 140. The hub is configuredto couple to a handle or handpiece 177 which can be manipulated by auser (e.g., a surgeon). The handpiece 177, in turn may be coupled to anintegrated power console or IPC 179 for driving the device 100 andspecifically for controlling rotation of inner shaft 140. The IPC 179may also include a fluid source (not shown) and may provide fluiddelivery to device 100.

Proximal end region 110 also includes a fluid source connector 150, apower source connector 160 and a suction source connector 170 forconnection to a fluid source 152, a power source, 162 and/or a suctionsource of system 10. One fluid useful with the present disclosure issaline, however, other fluids are contemplated. Power source 162 may bea generator and optionally may be designed for use with bipolar energyor a bipolar energy supply. For example, the Transcollation® sealingenergy supplied by the Aquamantys® System (available from MedtronicAdvanced Energy of Portsmouth, N.H.) may be used. Both the fluid source152 and suction source 172 are optional components of system 10.However, use of fluid in conjunction with energy delivery aids inproviding optimal tissue effect as will be further explained, thusembodiments of the present invention include specific arrangement of thedevice 100 for coupling of energy with a fluid. In use, a fluid (e.g.,saline) may be emitted from an opening at the distal end region of thedevice 100. Tissue fragments and fluids can be removed from a surgicalsite through an opening (not shown in FIG. 1) in the distal end regionvia the suction source 172, as will be further explained below.

FIG. 2 shows an enlarged perspective view of distal end portion 120 ofdevice 100. The outer shaft 130 includes a window or opening 134 at adistal end 135 of the outer shaft 135. Window 134 is defined by an outershaft cutting edge or cutter 132, which comprises cutting teeth 133. Theouter shaft 130 may be rigid or malleable or combinations thereof andmay be made of a variety of metals and/or polymers or combinationsthereof, for example may be made of stainless steel. A distal portion148 of the inner shaft 140 can be seen through the window or opening 134of outer shaft 130. In FIG. 1, inner shaft 140 is depicted in a positionsuch that an inner shaft cutting edge or cutter 141 (FIG. 3), comprisingcutting teeth 143 is facing an inner wall (not shown) of outer shaft130. Cutter 141 defines an inner shaft window or opening 154 (FIG. 3).Outer and inner shaft cutters 132 and 141 may move relative to oneanother in oscillation or rotation (or both) in order to mechanicallycut tissue. For example, outer shaft cutter 132 may remain stationaryrelative to the hub 175 and button assembly 200 while the inner shaftcutter 141 may rotate about a longitudinal axis A of the device, therebycutting tissue.

Rotation of inner shaft 140 may be achieved via manipulation of hub 175(FIG. 1). that can orient the inner shaft 140 relative to the outershaft 130 and may additionally allow for locking of the inner shaftrelative to the outer shaft in a desired position, i.e., inner shaft maybe locked in position when cutter 141 is facing down and electrodeassembly 142 is facing up. As described above, hub 175 may be connectedto a handle or handpiece 177 which may be controlled by an IPC 179.Alternatively, the hub 175 and/or handle portions may be manipulatedmanually. Inner shaft 140 may be selectively rotated to expose anelectrode assembly 142 comprising electrodes 142 a, 142 b, throughopening 134 of outer shaft 130, as shown in FIG. 2. Electrodes 142 a,142 b may comprise electrode traces and the electrode traces may extendfrom the distal portion 148 of the inner shaft to a proximal end 151(FIG. 10) of the inner shaft 140. As depicted in FIG. 2, inner shaft 140is positioned such that the inner shaft cutter 141 is facing theinterior (not shown) of outer shaft 130 and may be said to be in adownward facing direction and comprise a downward position. In thedownward position, tissue is shielded from the inner shaft cutter 141during hemostasis (via energy delivery through electrodes 142 a, 142 b),thereby delivering energy to tissue with no attendant risk that thecutting teeth 143 of the inner shaft 140 will diminish the efforts toachieve hemostasis. Device 100 may thus comprise two modes: a cutting ordebridement mode and a sealing or hemostasis mode and the two modes maybe mutually exclusive, i.e. hemostasis is achieved via energy deliveryto tissue while cutters 132, 141 are not active or cutting. As describedbelow, energy may be advantageously delivered simultaneously with afluid such as saline to achieve an optimal tissue effect by deliveringcontrolled thermal energy to tissue.

As depicted in FIG. 3, when the inner shaft 140 is oriented such thatthe cutter 141 is in the downward position, rotating inner shaft 140approximately 180 degrees relative to the outer shaft 130 will exposeinner shaft cutter 141 and inner shaft opening 154 through the outershaft opening 134. When the inner shaft cutter 141 is positioned asshown in FIG. 3, the inner shaft cutter 141 may be said to be in anupward position. The inner shaft opening 154 is fluidly connected to aninner shaft lumen 156, a portion of which can be seen in FIG. 7. Lumen156 extends from the inner shaft distal portion 148 to the proximal end151 (FIG. 10) of inner shaft 140 and may be fluidly connected with thesuction source 172. With this configuration, tissue cut via inner andouter shaft cutters 141, 132 may be aspirated into the inner shaft lumen156 through the inner shaft opening 154 upon application of suctionsource 172, thereby removing tissue from a target site.

With reference between FIGS. 4 and 5, the inner shaft 140 comprises aproximal assembly 168 including a proximal assembly shaft component 169(more clearly seen in FIG. 5) and electrodes 142 a and 142 b. Innershaft 140 also includes a joining assembly 144, which may be anon-conductive component and more specifically may comprise a liquidcrystal polymer (LCP) overmold assembly. The joining assembly 144 mayeffectively join or connect the distal portion 148 of inner shaft 140with the proximal assembly shaft component 169 (most clearly depicted inFIG. 5). Joining assembly 144 includes an extension portion 146 whichaids in minimizing arc tracking from the electrodes 142 a and 142 b aswill be further elucidated in the following discussion.

Electrodes or electrode traces 142 a and 142 b comprise bipolarelectrodes and may comprise wet or dry electrodes. Electrodes 142 a and142 b may be used to deliver any suitable energy for purposes ofcoagulation, hemostasis or sealing of tissue. Electrodes 142 a and 142 bare particularly useful with fluid such as saline provided by fluidsource 152 (FIG. 1) which may be emitted near the outer shaft opening134. Outer shaft opening 134 is fluidly connected to an outer shaftlumen 136, shown in phantom in FIG. 7. Lumen 136 extends from outershaft opening 134 to the proximal end region 110 of device 100 and maybe fluidly connected to the fluid source 152 (FIG. 1). Thus, fluid canbe delivered to the opening 134 of outer shaft 130 and interacts withelectrode traces 142 a, 142 b, as will be further described withreference to FIG. 1. In this manner, electrode traces 142 a and 142 bcan advantageously provide Transcollation® sealing of tissue when usedwith the Transcollation® sealing energy supplied by the AquamantysSystem, available from the Advanced Energy Division of Medtronic, Inc.With respect to “wet” RF coagulation technology, the technology forsealing tissue described in U.S. Pat. Nos. 6,558,385; 6,702,810,6,953,461; 7,115,139, 7,311,708; 7,537,595; 7,645,277; 7,811,282;7,998,140; 8,048,070; 8,083,736; and 8,361,068 (the entire contents ofeach of which is incorporated by reference) describe bipolar coagulationsystems believed suitable for use in the present invention. Othersystems for providing a source of energy are also contemplated.

Both FIGS. 4 and 5 depict the distal end region 120 of device 100, withouter shaft 130 removed. FIG. 4 shows a portion of the inner shaft 140coaxially maintained in an insulation liner or sheath 180. The liner 180may extend from a location proximal the inner shaft cutter 141 andcutting teeth 143, along inner shaft 140, to the proximal end 151 ofinner shaft 140. Liner 180 provides insulation between the inner andouter shafts 130, 140, thus providing electrical isolation of theelectrodes 142 a and 142 b from outer shaft 130 as well as from oneanother while only adding a single, very thin layer to the overalldevice 100. Liner 180 may be made of any suitable material, for example,fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), orany other material suitable as a non-conductive or electricallyinsulative material. Regardless, liner 180 is constructed so as to benegligible in its contribution to the overall diameter of the device 100and particularly the distal end region 120 of the device 100.

FIG. 5 shows the distal end region 120 of device 100 with both the outershaft 130 and the insulation liner 180 removed, thus exposing onlyportions of inner shaft 140. As described above, inner shaft 140includes a distal portion 148, which includes cutter 141, and an innershaft proximal assembly 168 including proximal assembly shaft component169. The individual distal portion 148 and shaft component 169 can beseen more clearly in FIG. 7 in which the joining assembly 144 andelectrodes 142 a, 142 b are removed. The proximal assembly shaftcomponent 169 may comprise a variety of suitable materials and forexample, may comprise a liquid crystal polymer (LCP) extruded shaftcomponent that is configured to support the placement of metallizedconductors (e.g., electrodes 142 a, 142 b) and may support overmolding(e.g. of joining assembly 144) and/or a plating process, such asdescribed below. Proximal assembly shaft component 169 may undergo alaser etching process to form the depressed areas 145 suitable forelectrode placement or plating. Other methods of forming the depressedareas 145 are also contemplated. FIG. 6 shows inner shaft 140 with theelectrodes or electrode traces 142 a, 142 b removed from the proximalportion 168 and joining assembly 144. Electrodes 142 a and 142 b may beformed on the proximal assembly shaft component 169 and on a portion ofjoining assembly 144 in a plating process for forming electrode traces.The portion over which the electrode traces may be applied includesdepressed areas 145 (FIG. 6), which may be laser etched areas. Oneprocess of electrode plating may include first applying coppersufficient to conduct the desired power and then adding nickel and goldlayers to the laser etched area 145. Other metals and combinations ofmetals are also contemplated, for example, silver may be used or anyother metal or combination of metals effective in providing a crosssection which meets power requirements for the energy delivery.Regardless, the plating process and overall electrode 142 a, 142 bthickness or depth is configured such that the electrodes 142 a, 142 bdo not negatively impact the diameter of the device 100. As but oneexample, the electrode plating process may result in a dimensionalchange to the overall diameter as little as 0.0015″.

FIG. 5 also more fully depicts joining assembly 144 which joins thedistal portion 148 with the inner shaft proximal assembly 168 of theinner shaft 140. As seen in FIG. 5, portions of distal portion 148 andproximal assembly shaft component 169 may be configured in a “puzzlepiece” arrangement as is indicated at joining assembly 144 which followsthe lines of the puzzle piece. Each of the distal portion 148 andproximal assembly shaft component 169 include a mating edge 192, 190,respectively. This configuration distributes forces acting on the innershaft 140 when the device 100 is in a cutting mode to aid in a securecoupling of the distal portion 148 and shaft component 169. The joiningassembly extension portion 146 is located between electrodes 146 a and146 b. This extension portion 146 provides adequate space between theelectrodes 146 a, 146 b to mitigate arc tracking between the two and toimprove the tissue depth effect.

Returning to FIG. 1, when fluid from fluid source 152 is providedthrough lumen 136 of the outer shaft 130, the fluid may travel betweenthe outside diameter of the inner shaft 140 and the inside diameter ofthe outer shaft 130 to the distal end 120 of device 100. Fluid travelsdistally down the lumen 136 of outer shaft 130 and may “pool” in an areashown in FIG. 1 as essentially defined by the opening 134 of outer shaft130. Likewise, electrodes 142 a and 142 b may be located slightly belowthe surface of the joining assembly 144 and/or the inner shaft proximalportion 168 (FIGS. 4, 5), creating another area for fluid pooling. Thisdepressed electrode 142 a, 142 b surface can also prevent wear of theelectrodes 142 a, 142 b. Pooling of fluid at the electrodes 142 a, 142 ballows for effective interaction between the fluid and the electrodeswhich in turn can provide effective and advantageous sealing of tissue,and in particular may provide effective Transcollation® sealing oftissue.

With continued reference to FIG. 1, electrodes 142 a and 142 b aresituated in an area generally centrally located with respect to theouter shaft opening 134 when inner shaft cutter 141 is in a downwardposition. This generally central location of the electrodes 142 a, 142 ballows for energy delivery at an optimal point of debridement. In otherwords, after inner shaft cutter 141 and outer shaft cutter 132 arerotated or oscillated relative to one another to cut tissue, rotatinginner shaft cutter 141 to the downward position to expose electrodes 142a, 142 b and deliver energy through the electrodes 142 a, 142 b mayallow for hemostasis in an area generally central to where debridementor cutting of tissue had taken place. The generally centered electrodes142 a, 142 b allow for energy to essentially travel or radiate outwardlyfrom the electrodes 142 a, 142 b to coagulate the approximately theentire area of tissue previously cut. In other words, energy, andparticularly RF energy may be provided at the center or near center of aportion of tissue previously cut or debrided.

FIGS. 8 and 9 depict an alternative outer shaft 130 and inner shaft 140whereby an outer shaft window or opening 134 a is essentially enlargedas compared to outer shaft window 134 (FIG. 2) via a proximal windowportion 138. This enlarged opening 134 a may afford an inner shaft 140having significantly larger electrodes 142 c, 142 d, such as depicted inFIG. 9. Electrodes 142 c, 142 d may be otherwise constructed similar toelectrodes 142 a and 142 b (e.g., FIG. 2) and the remaining portions ofinner shaft 140 may be constructed as described above.

FIG. 10 depicts a section of proximal assembly 168 of inner shaft 140which section, when assembled in device 100, is generally situatedwithin button activation assembly 200 (FIG. 1). Electrodes 142 a and 142b are shown as individual traces separated by proximal assembly shaftcomponent 169, which isolates the electrode traces 142 a, 142 b from oneanother. Electrodes 142 a includes a proximal portion comprising apartial ring 300 extending at least partially circumferentially aroundproximal assembly shaft component 169. Likewise electrode 142 bcomprises a proximal portion comprising a ring 301 which may extendfully circumferentially around proximal assembly shaft component 169 asdepicted in FIG. 10. Rings 300 and 301 provide contact surface area forelectrical contacts such as clips 216 a, 216 b (FIGS. 12, 14).

FIGS. 11-14 depict the button activation assembly 200 and the way inwhich energy provided to electrodes 142 a, 142 b. FIG. 11 shows apartial cutaway view of the button activation assembly 200 one housinghalf 204 b (FIG. 12) removed such that only housing half 204 a is shownleaving portions of the button activation assembly 200 exposed. As shownin FIG. 11, at the proximal end region 110 of device 100 is provided afluid housing 156 connected to the fluid connector 150 and an electricalcontact housing 210 connected to the power source connector 160. Thepower source connector 160 is in turn coupled to a power cord or cable161 comprising wires 161 a, 161 b and 161 c. Power cord 161 is coupledto a printed circuit board (PCB) 206 via wires 161 a, 161 b and 161 c.In addition, electrical contacts 164 and 166 electrically couple thepower cord to caps 208 a and 208 b, as further explained with referencetop FIGS. 12-14.

FIG. 12 shows and exploded view of the button activation cell 200 ofFIG. 11 as well as a portion of proximal end region 110 with portions ofthe button activation cell removed. FIG. 13 shows an enlarged view ofthe portion of proximal end region 110 shown in FIG. 13 with stillfurther portions removed. With reference between FIGS. 12-14, FIG. 12shows two housing halves 204 a and 204 b which may be attached via anyattachment device such as screws 400 and may, as described above, housevarious components of the button activation cell 200 as well as thefluid housing, electrical contact housing 210 and clip housing 220. Alsodepicted in FIG. 12 are o-rings 158 a, 15 b are adjacent fluid housing156 and an o-ring 228 which is adjacent housing 220 for sealing fluidfrom the various components, including the electrical componentsprovided in electrical contact housing 210.

Clip housing 220, shown alone or apart from cell 200 in FIG. 12,comprises two windows 224 a, 224 b. Clips 216 a and 216 b are providedin windows 224 a, 224 b with a flag 218 a, 218 b of each clip 216 a and216 b viewable through or adjacent to windows 224 a, 224 b, such asdepicted in assembled form in FIG. 13. Attached to clip housing 220 aretwo retaining rings 222 a, 222 b, for retaining the clips 216 a and 216b in housing 220. As best seen in FIG. 14, post connectors 214 a, 214 bare coupled to clip flags 218 a, 218 b and provided on post connectors214 a, 214 b are springs 212 a, 212 b. Over post connectors 214 a, 214 band springs 212 a, 212 b are provided caps 208 a, 208 b. Also as bestseen in FIG. 14, clips 216 a and 216 b are coupled to an in contact withrings 300 and 301 respectively of electrode traces 142 a, 142 b. Clips216 a, 216 b, post connectors 214 a,b, springs 212 a, 212 b and caps 208a, 208 b are made of an electrically conductive material and provideelectrical contact of the caps 208 a, 208 b to rings 300 and 301 when asource of power is activated or applied at caps 208 a, 208 b. As seen inFIGS. 11 and 12, the caps 208 a, 208 b are provided under the PCB 206,over which is provided button 202. Depressing button 202 drives a buttoncontact assembly 203 which in turn moves to close circuitry of the PCB206 allowing a pathway for current to flow from the power source 162thus providing power to the electrodes 142 a, 142 b through the clips216 a, 216 b as described above.

When energy is activated or applied to clips 216 a, 216 b, due to theintimate contact of clips 216 a and 216 b with electrode rings 300 and301, electrical communication with bipolar electrodes 142 a, 142 b isachieved whereby energy is delivered along electrode traces 142 a and142 b to the distal end 120 of device 100 and is applied to a targetedarea of tissue as described herein above. This aspect of the presentdisclosure integrates electrodes 142 a and 142 b to the inner shaft 140while isolating the inner shaft and electrodes 142 a and 142 b fromother components and while distributing the required power to twoseparate and distinct electrodes 142 a, 142 b. This design alsominimizes the number of layers required to make the distal end 120 ofthe device.

FIG. 15 is a top view of the button activation assembly 200 and depictsan alignment fiducial 420 through a window 430 in housing 204. Alignmentfiducial 420 is provided on housing 221 (FIG. 13). The alignmentfiducial 420 is one of two fiducials which may be provided on device100, with the second fiducial not shown. Alignment fiducials (e.g., 420)are provided as indicators of alignment of inner cutter 141 and may becolored to indicate a particular alignment configuration.

Various modifications and alterations to this disclosure will becomeapparent to those skilled in the art without departing from the scopeand spirit of this disclosure. It should be understood that thisdisclosure is not intended to be unduly limited by the illustrativeembodiments and examples set forth herein and that such examples andembodiments are presented by way of example only with the scope of thedisclosure intended to be limited only by the claims set forth herein asfollows.

What is claimed is:
 1. A method of surgically cutting and sealing tissuecomprising: positioning a distal end region of a debridement device atan operative site within a patient, the debridement device having anouter shaft comprising a lumen and a distal end comprising a cutterforming a cutting window, the device further comprising an inner shaftrotatably disposed within the lumen of the outer shaft, the inner shafthaving a distal portion comprising a cutter forming a cutting window,the outer shaft and the inner shaft forming a fluid passagetherebetween, the device further comprising a bipolar electrode assemblyincluding first and second electrodes that are electrically isolatedfrom one another and positioned at the distal end region, the bipolarelectrode assembly further including first and second electricalcontacts coupled to the first and second electrodes, respectively, thedevice further comprising a proximal region opposite the distal endregion and including housing maintaining a button, the button beingmanually transitionable to an activation position; grasping the housingby a hand of a user; cutting tissue at the operative site with the innershaft cutter and the outer shaft cutter by moving the inner shaftrelative to the outer shaft; transitioning the button to the activationposition, including simultaneously completing an electrical pathwaybetween each of the first and second electrical contacts and an energysource; delivering bipolar RF energy to the first and second electrodesin response to the button being held in the activation position to applyRF energy to tissue of the operative site; and terminating the deliveryof bipolar RF energy to the first and second electrodes upon releasingthe button from the activation position.
 2. The method of claim 1,wherein the step of transitioning is performed by a finger of the user'shand otherwise simultaneously grasping the housing.
 3. The method ofclaim 1, wherein the step of transitioning includes depressing thebutton relative to the housing.
 4. The method of claim 1, furthercomprising discontinuing the delivery of bipolar RF energy when thebutton is manipulated away from the activation position.
 5. The methodof claim 4, wherein the button is provided as part of a button assembly,the button assembly further including a biasing member biasing thebutton away from the activation position.
 6. The method of claim 1,wherein the button is operatively associated with first and secondresilient members, and further wherein the activation position includesthe first and second resilient members electrically coupled to the firstand second electrical contacts, respectively.
 7. The method of claim 6,wherein the first and second resilient members are located within thehousing.
 8. The method of claim 6, wherein the step of transitioning thebutton to the activation position includes establishing electricalcommunication between a source of energy and the first and secondelectrical contacts.
 9. The method of claim 1, wherein the step ofdelivering bipolar RF energy includes effecting hemostasis at theoperative site.
 10. The method of claim 1, further comprising supplyingfluid to the bipolar electrode assembly simultaneously with the step ofdelivering bipolar RF energy such that the fluid is operatively coupledto the bipolar electrode assembly.
 11. The method of claim 10, whereinthe step of supplying fluid to the bipolar electrode assembly includesdelivering the fluid to the bipolar electrode assembly via the fluidpassage.
 12. The method of claim 1, wherein after the step of cuttingtissue and prior to the step of transitioning the button, the methodfurther comprising: arranging the debridement device in a home positionin which the inner shaft cutter is shielded; and enabling an RF energymode in which the debridement device is maintained in the home position.13. The method of claim 12, wherein the step of delivering bipolar RFenergy includes supplying bipolar RF energy while the RF energy mode isenabled.
 14. The method of claim 12, wherein the cutter of the innershaft includes a cutting surface at a perimeter of the inner shaftcutting window, and further wherein the home position includes thecutting surface disposed within the lumen of the outer shaft.
 15. Themethod of claim 12, wherein the home position includes the outer shaftcovering the inner shaft cutting window.
 16. The method of claim 12,wherein the home position includes the cutter of the inner shaft facinga direction opposite the cutter of the outer shaft.
 17. The method ofclaim 12, wherein the home position includes the first and secondelectrodes being exposed for electrically interfacing with tissue of theoperative site.
 18. A method of surgically cutting and sealing tissuecomprising: positioning a distal end region of a debridement device atan operative site within a patient, the debridement device having anouter shaft comprising a lumen and a distal end comprising a cutterforming a cutting window, the device further comprising an inner shaftrotatably disposed within the lumen of the outer shaft, the inner shafthaving a distal portion comprising a cutter forming a cutting window,the distal end region further comprising an electrode assembly, theouter shaft and the inner shaft forming a fluid passage therebetween;cutting tissue at the operative site with the inner shaft cutter and theouter shaft cutter by moving the inner shaft relative to the outershaft; arranging the debridement device in a home position in which theinner shaft cutter is shielded; enabling an RF energy mode in which thedebridement device is maintained in the home position; and supplying RFenergy to the electrode assembly while the RF energy mode is enabled toapply RF energy to tissue of the operative site.
 19. The method of claim18, wherein the cutter of the inner shaft includes a cutting surface ata perimeter of the inner shaft cutting window, and further wherein thehome position includes the cutting surface disposed within the lumen ofthe outer shaft.
 20. The method of claim 19, wherein the cutting surfaceincludes a plurality of teeth each terminating at a tip, and furtherwherein the home position includes the tip of each of the plurality ofteeth not being exposed at the outer shaft cutting window.
 21. A methodof surgically cutting and sealing tissue comprising: positioning adistal end region of a debridement device at an operative site within apatient, the debridement device having an outer shaft comprising a lumenand a distal end comprising a cutter forming a cutting window, thedevice further comprising an inner shaft rotatably disposed within thelumen of the outer shaft, the inner shaft having a distal portioncomprising a cutter forming a cutting window, the outer shaft and theinner shaft forming a fluid passage therebetween, the device furthercomprising a bipolar electrode assembly including first and secondelectrodes that are electrically isolated from one another andpositioned at the distal end region; cutting tissue at the operativesite with the inner shaft cutter and the outer shaft cutter by movingthe inner shaft relative to the outer shaft; indicating a rotationalrelationship of the inner shaft relative to the outer shaft appropriatefor provision of bipolar RF energy to the first and second electrodes;and supplying bipolar RF energy to the first and second electrodes toapply RF energy to tissue of the operative site.